FDA.reportPublic FDA data

MassTrak

Primary DI
00816776020568
Brand
MassTrak
Company
WATERS TECHNOLOGIES CORPORATION
Model
186010565IVD
Catalog number
186010565IVD
Device description
MassTrak™ Steroid Serum Cal Set 3
Published
2023-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JIXCalibrator, Multi-Analyte Mixture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816776020568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816776020568008167760205688167760205680816776020568

GMDN Terms#

Term, Definition table
TermDefinition
Multiple steroid hormone IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple steroid hormones in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-10 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-252-4752customerservice@waters.com

Regulatory Flags#

DUNS number
107186004
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816776020551MassTrak186010565IVD186010564IVD2023-12-05
00816776020247MassTrak186010560IVD186010560IVD2022-12-22
00816776020544MassTrak186010563IVD186010563IVD2023-12-05
00816776020575MassTrak186010566IVD186010566IVD2023-12-05
00816776020582MassTrak186010568IVD186010568IVD2023-12-05
00816776020599MassTrak186010567IVD186010567IVD2023-12-05
00816776020254Xevo186009782IVD186009782IVD2023-04-06
00816776020421MassTrak186009311IVD186009311IVD2021-10-25
00816776020438MassTrak186009312IVD186009312IVD2021-10-25
00816776020445Acquity186015082IVD186015082IVD2022-03-01
00816776020452Acquity186015088IVD186015088IVD2022-03-01
00816776020469Acquity186015087IVD186015087IVD2022-03-01
00816776020476Acquity186015014IVD186015014IVD2022-03-01
00816776020315Acquity725000662IVD725000662IVD2021-10-06
00816776020346Xevo186008453IVD186008453IVD2021-10-06
00816776020179Xevo186007833IVD186007833IVD2021-10-05
00816776020087Acquity186015007IVD186015007IVD2021-10-04
00816776020094Acquity186015010IVD186015010IVD2021-10-04
00816776020100Acquity186015020IVD186015020IVD2021-10-04
00816776020117Acquity186015043IVD186015043IVD2021-10-04

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Primary DI, Brand, Company table
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00850083817039Solomon Commutable Quality MaterialsSolomon Park Research Laboratories, Inc.JIX2026-04-06
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10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
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00852676007063Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JIX2023-08-09
08430793040518Aptiva® Celiac Disease IgG CalibratorsINOVA DIAGNOSTICS, INC.JIX2022-05-27
08430793040570Aptiva® Celiac Disease IgA CalibratorsINOVA DIAGNOSTICS, INC.JIX2022-05-27
14987481102924Multi Calibrator LipidsFUJIFILM WAKO PURE CHEMICAL CORPORATIONJIX2020-10-23
00380740161378ARCHITECTAbbott GmbHJIX2020-09-18
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00630414284972N Rheumatology Standard SLSiemens Healthcare Diagnostics Products GmbHJIX2020-02-14
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04250317543370Urine Calibration StandardChromsystems Instruments + Chemicals GmbHJIX2019-03-22
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